Is NCT05603715 recruiting in Burlington, VT?

Yes, NCT05603715 is currently recruiting participants at its Burlington, VT location. This parkinson disease clinical trial is actively enrolling qualified participants.

How do I join the parkinson disease clinical trial in Burlington?

To join this clinical trial in Burlington, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Burlington clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Parkinson Disease Clinical Trial in Burlington, VT

About This Parkinson Disease Study in Burlington

Constipation is a common and debilitating non-motor symptom of Parkinson disease (PD) that often precedes the onset of classic motor symptoms by decades. There is no standardized algorithm for managing constipation in this patient population, nor are there dedicated treatments. Studies suggest that constipation can affect quality of life to a significant degree, in many cases just as much as motor symptoms. There is an unmet need for effective treatment options for constipation in this patient population. The goal of this study is to determine the efficacy and safety of pyridostigmine as a treatment for chronic constipation in patients with PD.

Sponsor: University of Vermont Medical Center

Who Can Participate

Inclusion Criteria

Age ≥ 18 years

Be able to provide signed informed consent

Stated ability and willingness to comply with all study procedures

Able to take oral medications

Females of reproductive potential who are sexually active must be willing to use two of the following highly effective methods of contraception for the duration of study participation and for an additional 28 days after the end of study drug administration: barrier contraception (female condom, diaphragm, cervical cap with/without spermicide), hormonal contraception, or intrauterine device; OR one of the previously mentioned methods AND partner must use barrier contraception (male condom with/without spermicide)

Males of reproductive potential who are sexually active must be willing to use the following highly effective methods of contraception for the duration of study participation and for an additional 28 days after the end of study drug administration: barrier contraception (male condom with/without spermicide) AND partner must be postmenopausal, use hormonal contraception, have an intrauterine device, or use barrier contraception (female condom, diaphragm, cervical cap with/without spermicide)

Meet United Kingdom Parkinson's Disease Society Brain Bank Criteria: A. Diagnosis of a parkinsonism:

Bradykinesia, plus at least one of the following:

Muscular rigidity

4-6 Hz resting tremor

Postural stability not caused by primary visual, vestibular, cerebellar or proprioceptive dysfunction B. At least three supportive criteria:

Unilateral onset of symptoms

Rest tremor

Progressive symptoms

Persistent asymmetry affecting the side of onset most

Excellent response to levodopa

Severe levodopa-induced chorea

Levodopa response for five years or more

Clinical course of 10 years or more

Fulfill the ROME IV Criteria for Functional Constipation, with a specific requirement that the patient must have three or fewer defecations per week (criterion Ai):

Must include two or more of the following: i. Three or fewer defecations per week ii. Straining during \> 25% of defecations iii. Lumpy or hard stools in \> 25% of defecations iv. Sensation of incomplete evacuation for \> 25% of defecations v. Sensation of anorectal obstruction/blockage for \> 25% of defecations vi. Manual maneuvers to facilitate \> 25% of defecations

Loose stools are rarely present without the use of laxatives

Insufficient criteria for irritable bowel syndrome

Criteria 1-3 must be fulfilled for at least three months with onset of symptoms at least six months prior to diagnosis

Exclusion Criteria

Diagnosis of atypical parkinsonism

Diagnosis of drug-induced parkinsonism

Diagnosis of vascular parkinsonism

Known allergy to pyridostigmine bromide or other study drug components

Current or recent (within 90 days of enrollment) use of pyridostigmine for any reason

History of any bowel surgery

History of bladder or bowel obstruction

Severe asthma or chronic obstructive pulmonary disease

Meet exclusion criteria noted in the UK Parkinson's Disease Society Brain Bank Criteria, at the PI's discretion: A.Exclusion of any of the following:

Repeated strokes with stepwise progression of parkinsonian features

Repeated head injury

Definite encephalitis

Oculogyric crises

Neuroleptic treatment at onset of symptoms

Greater than one affected relative

Sustained remission

Strictly unilateral features after 3 years

Supranuclear gaze palsy

Cerebellar signs

Early severe autonomic involvement

Early severe dementia

Babinski sign

Cerebral tumor or communicating hydrocephalus

Negative response to large doses of levodopa

1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine exposure

Significant abnormalities on laboratory analysis (complete blood count, comprehensive metabolic panel, thyroid stimulating hormone) conducted at the screening visit or within the three months prior if available for review

Significant abnormalities on screening electrocardiogram conducted at the screening visit or within the three months prior if available for review

Positive pregnancy test (if female of child-bearing age)

Antibiotic use within two weeks prior to enrollment

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Burlington?

Yes, this clinical trial (NCT05603715) has an active research site in Burlington, VT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Parkinson Disease Treatment Options in Burlington, VT

If you're searching for parkinson disease treatment options in Burlington, VT, this clinical trial (NCT05603715) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Burlington research site is actively enrolling participants for this clinical trial. You'll receive care from experienced parkinson disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all parkinson disease clinical trials near you to find additional studies recruiting in your area.

Parkinson Disease Clinical Trial in Burlington, VT

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